Senior Drug Stability Indicating Method Specialist

Job Title:

Senior Drug Stability-Indicating Method Specialist

Location: United Arab Emirates (Remote)

Employment Type: Full-Time

Work Arrangement: 100% Remote — Work From Home

Level: Senior

We are seeking an experienced Senior Drug Stability-Indicating Method Specialist to support the development, evaluation, validation, and ongoing oversight of analytical methods used to assess pharmaceutical product stability. This role focuses on reviewing analytical method performance, assessing degradation pathways, evaluating forced degradation studies, and ensuring that stability-indicating methods can reliably distinguish active pharmaceutical ingredients from degradation products, impurities, and excipients. The successful candidate will bring strong pharmaceutical analytical chemistry expertise, knowledge of stability testing principles, and experience with regulated laboratory documentation.

• Provide technical oversight for the development and evaluation of stability-indicating analytical methods for pharmaceutical products.
• Review analytical method development strategies for active pharmaceutical ingredients, finished dosage forms, and relevant pharmaceutical intermediates.
• Assess forced degradation study designs and evaluate evidence of degradation under appropriate stress conditions.
• Review chromatographic methods, particularly HPLC and UPLC, for their ability to separate active ingredients from degradation products and related impurities.
• Evaluate analytical specificity, selectivity, sensitivity, precision, accuracy, linearity, range, and robustness.
• Review method validation and verification protocols, results, acceptance criteria, and supporting technical documentation.
• Assess chromatograms, peak purity results, impurity profiles, mass balance calculations, and degradation trends.
• Review the suitability of analytical techniques such as HPLC, UPLC, GC, UV-Visible spectroscopy, and LC-MS where applicable.
• Analyze degradation pathways and assess the potential formation and behavior of relevant degradation products.
• Evaluate analytical method performance across different formulations, strengths, packaging configurations, and stability conditions.
• Review stability study data generated under long-term, accelerated, intermediate, and other applicable storage conditions.
• Assess analytical trends and investigate atypical results, out-of-specification findings, and out-of-trend observations.
• Review analytical method transfer, verification, and lifecycle management documentation.
• Coordinate with analytical development, quality control, quality assurance, formulation, and regulatory affairs teams.
• Assess the impact of formulation changes, manufacturing process changes, and raw material variations on analytical method suitability.
• Review laboratory investigations, deviations, change controls, and corrective and preventive action documentation related to stability testing.
• Support preparation and technical review of stability study reports, analytical method reports, and regulatory dossier sections.
• Monitor relevant ICH guidance, pharmacopeial requirements, and applicable regulatory expectations for analytical procedure development and validation.
• Recommend improvements to analytical procedures, data review practices, and method performance monitoring.

• Bachelor's or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, Pharmaceutical Analysis, or a related discipline.
• Significant experience in pharmaceutical analytical development, stability testing, analytical method validation, or quality control.
• Strong understanding of stability-indicating method development and pharmaceutical degradation chemistry.
• Practical knowledge of forced…